JP6202636B2 - Apparatus, system and method for positioning a marker or tissue structure in a body - Google Patents

Description

  The present invention relates generally to devices and methods for performing surgical procedures, and in particular to surgical procedures such as, for example, tumor extraction surgery, for targeting, markers, lesions, and / or other body structures within a patient's body. Alternatively, it relates to an apparatus and method for positioning while performing other procedures.

  Before performing a surgical procedure to remove a lesion in the chest, such as a biopsy or a tumor removal operation, the location of the lesion must be identified. For example, mammography or ultrasound imaging can be used to locate and / or confirm the location of the lesion prior to treatment. The resulting image identifies the location of the lesion and, for example, during an incision to access the lesion and / or during a procedure that guides the surgeon to remove the lesion. Used by surgeons. However, such an image is usually a two-dimensional image, and the chest and the lesion to be removed are three-dimensional structures, thus providing only limited guidance for locating the lesion. Furthermore, such images provide only limited guidance in determining an appropriate margin around the lesion, i.e. in determining the desired sample volume to be removed.

  To facilitate positioning, a wire can be inserted into the chest, for example using a needle, just before the procedure, so that the tip of the wire is at the lesion location. Once the wire is placed, for example, a bandage or tape can be applied to the patient's skin from which the wire comes out of the chest to secure the wire in place. Using the wire placed and fixed in place, the patient can perform, for example, a surgical procedure to perform a biopsy or a tumor removal operation.

  One problem with using a wire for positioning is that the wire may move between placement and the surgical procedure. For example, if the wire is not sufficiently fixed, the wire may move relative to the path used to access the lesion, and as a result, the tip may incorrectly display the location of the lesion. When this problem occurs, when accessing the location and removing the tissue, the lesion may not be completely removed and / or healthy tissue may be unnecessarily removed. In addition, during this procedure, the surgeon only estimates the position of the wire tip and lesion based on, for example, mammography and other images acquired during placement of the wire, and the resection is performed without further guidance. Will do. Furthermore, because such images are two-dimensional images, they provide limited guidance for identifying lesions to be treated or removed.

  Alternatively, it has been suggested that radioactive seeds be placed and positioned during the procedure. For example, a needle can be introduced into the lesion through the chest and the seed can be deployed from the needle. The needle can be pulled out and the seed position can be confirmed using mammography. During a series of surgical procedures, a portable gamma probe can be placed over the chest to recognize the location on the seed, make an incision, and use the probe to guide the resection of the seed and lesion it can.

  Since the seed is delivered through a needle that is immediately removed, there is a risk that the seed will move within the patient's body during placement and surgical procedures. Therefore, as in the case of using the positioning wire, the seed may not accurately recognize the position of the lesion. In particular, there is no method for stabilizing the seed once placed from the outside. In addition, such gamma probes cannot provide the desired accuracy, for example, in three dimensions, in determining the location of the seed, and therefore can only provide guidance limited to the identification of lesions.

  Accordingly, an apparatus and method for positioning a lesion or other tissue structure prior to and / or during a surgical procedure, diagnosis, or other medical procedure is beneficial.

  The present invention relates to an apparatus and method for performing a surgical procedure or other medical procedure. In particular, the present invention relates to implantable markers and targets, markers, lesions, and / or other body structures within a patient's body prior to performing a surgical procedure or other procedure, such as, for example, a tumor extraction operation or The present invention relates to an apparatus and method for positioning in between.

  According to one embodiment, a system for positioning a target tissue region within a patient's body that includes one or more markers or targets; and a target is introduced into the target tissue region, in the vicinity of the target tissue region and / or the target tissue region A probe for transmitting and receiving an electromagnetic signal for detecting a target is provided after the probe is arranged toward the surface. The probe may include one or more output devices, such as a display, a speaker, etc., for example, spatial based on the spatial sensation of the target relative to the probe, such as the distance and / or angular orientation between the probe and target. Provide information. Optionally, the system introduces a target into tissue or the patient's body, such as a needle, cannula, or other tubular member, for example, into which one or more targets can be loaded. Or more delivery devices may be provided.

  In an exemplary embodiment, the target may comprise a plurality of inclined surfaces, which can enhance the reflection of electromagnetic signals from the probe. For example, the target provides a passive marker. For example, the target may be an elongate marker comprising a plurality of beads connected to the core element, the beads comprising an inclined surface and / or an edge to enhance detection by the probe. The core element may be based on one or more predetermined shapes such as, for example, corrugated, tapered helix, cylindrical helix, etc. Further, for example, the marker can be easily loaded into the delivery device. Therefore, it may be elastic enough to be straight. In other embodiments, the target may be spherical, elliptical, disc-shaped, or other shape, such as having one or more surface properties that enhance the reflection of electromagnetic signals. .

  Optionally, the target may comprise one or more circuits, mechanisms, etc. that modulate the incident signal from the probe to facilitate target positioning. For example, the target provides an active reflective marker. For example, the target imparts a phase shift to the signal from the probe that strikes the target, eg, to distinguish it from other targets, tissue structures, and the like. In another option, the target comprises a circuit and a power source, causing the target to generate a predetermined signal in response to detection of a signal from the probe, ie, providing an active response marker.

  Optionally, the target may comprise a marker releasably or substantially permanently coupled to the elongated flexible tether. Alternatively, the target may comprise a shaft and a positioning wire comprising a marker at the distal end of the shaft.

  According to another embodiment, a system is provided for locating a target tissue region within a patient's body, the system comprising one or more markers or sizes sized to be implanted in or around the target tissue region. A delivery device carrying the target; and an electromagnetic signal for detecting one or more markers implanted in or around the target tissue region when the probe is positioned near and / or toward the target tissue region And a probe for transmitting and receiving.

  In an exemplary embodiment, the delivery device is deliverable from the distal end and a shaft with a distal end sized to be introduced through the tissue in the patient's body to the target tissue region. With one or more markers. For example, the shaft includes a lumen, and a plurality of markers are conveyed within the lumen, and the markers are delivered sequentially from the shaft and implanted at or near a lesion or other target tissue region. Exemplary markers that can be delivered with the delivery device include passive markers, active reflective markers, and active response markers.

  According to yet another embodiment, a method for positioning a target tissue region within a patient's body is provided, the method comprising introducing a marker or other target through the tissue to the target tissue region; Positioning the probe relative to and / or toward the patient's skin or target tissue region; activating the probe so that the probe transmits an electromagnetic signal toward the target tissue region; Receiving, reflecting, or providing spatial information that receives the reflected electronic signal and provides a spatial relationship between the target and the probe.

  In one embodiment, the target may be a positioning wire introduced through the tissue into the target tissue region, which carries the target. In another example, the target may be one or more markers implanted within the target tissue region. In yet another embodiment, the target may be a catheter or other device that can be introduced into the target area and deployed to depict the volume or area, for example. The device may comprise a special structure configured to recognize and / or define its volume, for example using an electromagnetic probe. Optionally, the target may be placed before or during a diagnostic, therapeutic, and / or surgical procedure, for example, using a stereotactic, ultrasound, or electromagnetic wave-based imaging device. Also good.

  In an exemplary embodiment, the target tissue region may comprise a region in the chest of a patient having a lesion, and the target is delivered into or around the lesion. Alternatively, the target tissue region may be located in other regions of the body, such as in or around the intestine, fallopian tube, and the like. For example, the target may include a first marker that is introduced into a target tissue region at a distance from the lesion and defines a desired margin for removing the specimen volume from the target tissue region. Optionally, a second marker and / or a plurality of additional markers may be introduced into the target tissue region remote from the lesion and the first marker to further define the desired margin. Thus, if desired, a three-dimensional array marker can be placed in or around the target tissue region to facilitate its positioning. The tissue specimen can then be removed from the target tissue region. The specimen includes a lesion and a target.

  According to yet another embodiment, a method for removing a lesion in a target tissue region of a patient's chest is provided, the method comprising introducing a target through the chest tissue into the target tissue region; A space that provides a spatial relationship between the target and the probe, usually toward the target tissue region, near the patient's skin, transmitting an electromagnetic signal toward the target tissue region, receiving an electromagnetic signal reflected from the target Disposing a probe for providing information; removing a tissue specimen including a lesion and a target from a target tissue region.

  According to yet another embodiment, a method for removing a lesion in a target tissue region of a patient's chest is provided, the method comprising introducing a target through the chest tissue into the target tissue region; Locating a probe for transmitting an electromagnetic signal toward the target tissue region and receiving an electromagnetic signal reflected from the target in the vicinity of the patient's skin toward the target tissue region; Defining a desired margin within a surrounding target tissue region; removing a tissue specimen defined by the desired margin and including a lesion and target from the target tissue region.

  According to yet another embodiment, an implantable marker is provided for positioning a target tissue region within a patient's body, the marker comprising an elongated core member and a plurality of beads carried on the core member. Yeah. Optionally, the beads have multiple surfaces and / or edges to enhance electromagnetic signal reflection and facilitate marker positioning. In addition or alternatively, the marker may comprise, for example, an electronic circuit embedded in or carried on one of the beads or in the core member, whereby one of active reflection and active response. Can provide one.

  Other aspects and features of the present invention will become apparent by considering the following description with reference to the drawings.

FIG. 1 is a front view illustrating one embodiment of a system for positioning a target tissue region within a body having a positioning wire and a probe. FIG. 2A is a front view of a patient's body torso and shows the positioning wire shown in FIG. 1 inserted into a target tissue region in the chest, such as a tumor or other lesion. FIG. 2B is a cross-sectional view of the chest along line 2B-2B of FIG. 2A, showing the target on a positioning wire placed in the target tissue region. FIG. 3 is a cross-sectional view of the chest shown in FIGS. 2A and 2B, eg, an incision positioning wire target that measures the distance from the skin to the lesion, the desired margin, and / or the size of the specimen to be removed from the chest. Fig. 2 shows the probe of Fig. 1 being used to measure a first distance up to; FIG. 4 is a cross-sectional view of the chest shown in FIGS. 2A, 2B, and 3 after the initial excision has been performed, for example, whether the tissue has been excised enough to reach the desired margin of the specimen to be removed The probe being used to make the second distance measurement to determine FIG. 5 is a cross-sectional view of the resected tissue specimen taken from the chest of FIGS. 2A and 2B, eg, performing a third distance measurement to confirm that a desired margin has been achieved around the lesion The probe used for this is shown below. FIG. 6 is a perspective view of the chest, showing a delivery device being used to deliver multiple markers within the chest around one or more lesions, such as non-tactile lesions. FIG. 7 is a cross-sectional view of the chest shown in FIG. 6 and shows a plurality of markers arranged around the lesion. FIG. 8 is a cross-sectional view of the chest shown in FIGS. 6 and 7, showing a probe being used incorporating a first distance measurement set, for example, to measure distance to one or more markers. . FIG. 9 is a cross-sectional view of the chest shown in FIGS. 6-8 and is used, for example, to facilitate an incision up to the marker to define a desired margin around the specimen to be removed from the chest. Shows the probe being used. FIG. 10 is a schematic diagram illustrating an exemplary embodiment of a probe that can be included in various systems for marker positioning. FIG. 10A is a diagram illustrating an exemplary display output that can be provided on a probe, such as the probe instrument shown in FIG. 10B is a cross-sectional view of an antenna that can be provided in the probe shown in FIG. FIG. 11 is a diagram illustrating another exemplary embodiment of a system for identifying a target tissue region in the body, which includes a marker implanted in the chest, a handheld probe for positioning the marker, and a connection to the probe. A probe device having a connected controller. FIG. 12 is a side view of the system shown in FIG. 11 being used for marker positioning to facilitate removal of a tissue specimen from a breast containing a lesion. FIG. 13 is a side view of the system shown in FIG. 11 being used to position a marker that facilitates removal of a tissue specimen from a breast containing a lesion. FIG. 14 is a side view of the system shown in FIG. 11 being used to position a marker that facilitates removal of a tissue specimen from a breast containing a lesion. FIG. 14A shows the details of FIG. 14 and shows the probe being used to position the marker, thereby identifying the desired margin of the tissue specimen being removed from the chest. FIG. 15 is a side view of the system shown in FIG. 11 being used for marker positioning to facilitate removal of a tissue specimen from a breast containing a lesion. FIG. 15A shows the details of FIG. 15 and shows the probe being used to position the marker, confirming that the desired margin of the removed tissue specimen has been achieved. FIG. 16A is a perspective view of another exemplary embodiment of a probe instrument that includes a finger sack integral with the probe and a controller connected to the probe. FIG. 16B is a side view showing the details of the finger sack shown in FIG. 16A, and shows a state in which the finger is contained therein. FIG. 17 is a cross-sectional view of the chest that is implanted near the lesion and shows the markers identified using the probe instrument shown in FIGS. 16A and 16B while excising the breast tissue and removing the tissue specimen containing the lesion. FIG. FIG. 18 is a cross-sectional view of the breast, which is implanted near the lesion and shows the markers identified using the probe instrument shown in FIGS. 16A and 16B while excising the breast tissue and removing the tissue specimen containing the lesion. FIG. FIG. 19 is a side view illustrating yet another exemplary embodiment of a probe instrument comprising a cannula carrying a probe and a controller connected to the probe. FIG. 19A shows details of the pointed tip of the cannula shown in FIG. 19 with the probe therein. FIG. 20 is a cross-sectional view of the chest with a marker implanted in the vicinity of the lesion and shows a method of placing a cannula in the chest to provide access to the lesion site. FIG. 21 is a cross-sectional view of a chest with a marker implanted in the vicinity of the lesion, showing a method of placing a cannula in the chest to provide access to the lesion site. FIG. 22 is a cross-sectional view of a chest with a marker implanted in the vicinity of the lesion, showing a method of placing a cannula in the chest to provide access to the lesion site. FIG. 23A is a side view of a first exemplary embodiment of an elongated marker that can be implanted into tissue and identified using a probe. FIG. 23B is a cross-sectional view of the marker of FIG. 23A along the line 23B-23B. FIG. 23C is an end view of the marker of FIG. 23A. FIG. 23D is a side view of the marker of FIGS. 23A-23C having a waveform in the unfolded shape. 24A-24C are perspective, end, and side views, respectively, of beads that can be used to fabricate an implantable marker, such as the markers of FIGS. 23A-23D. FIG. 25A is a side view of an alternative embodiment of an elongated marker that can be implanted into tissue and identified using a probe. FIG. 25B shows details of the marker of FIG. 24A, showing features incorporated into the surface of the marker. FIGS. 26A-26C are side, perspective, and end views, respectively, showing another alternative embodiment of an elongated marker having a helical shape that can be implanted into tissue and identified using a probe. FIGS. 27A-27C are a perspective view, an end view and a side view, respectively, illustrating an exemplary embodiment of a spherical marker that can be implanted into tissue and identified using a probe. Figures 28A-28C are perspective views illustrating alternative embodiments of spherical markers that can be implanted into tissue and identified using a probe. 29A and 29B are side views illustrating an exemplary embodiment of a delivery cannula used to deliver the marker of FIG. 25 to the chest. FIG. 30A is a side view illustrating another exemplary embodiment of a delivery cannula for delivering a marker. FIG. 30B is a cross-sectional view of the delivery cannula of FIG. 30A along line 30B-30B. FIG. 31A is a side view of the delivery cannula of FIGS. 30A and 30B after delivery of the marker. FIG. 31B is a cross-sectional view of the delivery cannula of FIG. 31A along line 31B-31B. FIG. 32 is a cross-sectional view of the chest and illustrates a method of implanting the marker of FIG. 25 in the chest using the delivery cannula of FIGS. 30A-31B. FIG. 32A is a diagram showing details of a marker implanted in the chest shown in FIG. 32. FIG. 33 is a cross-sectional view of the chest and illustrates a method of implanting the marker of FIG. 25 in the chest using the delivery cannula of FIGS. 30A-31B. FIG. 33A is a diagram showing details of a marker implanted in the chest shown in FIG. 33. 34A and 34B are a side view and an end view, respectively, showing yet another example of an implant marker in tissue. FIG. 35 is a side view of an alternative embodiment of a marker device comprising the markers shown in FIGS. 34A and 34B coupled to an elongated tether. FIG. 36 is a cross-sectional view of the chest showing the delivery device delivering the marker of FIG. 35 and showing the method of introducing the delivery device into the chest to implant the marker in the vicinity of one or more lesions. FIG. 37 is a cross-sectional view of the chest showing the delivery device delivering the marker of FIG. 35 and showing a method for introducing the delivery device into the chest to implant the marker in the vicinity of one or more lesions. FIG. 38 is a cross-sectional view of the chest showing the delivery device delivering the marker of FIG. 35 and showing the method of introducing the delivery device into the chest to implant the marker in the vicinity of one or more lesions. FIG. 39 is a cross-sectional view of the chest showing the delivery device delivering the marker of FIG. 35 and showing the method of introducing the delivery device into the chest to implant the marker in the vicinity of one or more lesions. FIG. 40 is a cross-sectional view of the chest showing the delivery device delivering the marker of FIG. 35 and showing the method of introducing the delivery device into the chest to implant the marker in the vicinity of one or more lesions. 41A and 41B are side and end views showing yet another exemplary embodiment of a marker for implantation into tissue. 42 is a side view of an alternative embodiment of a marker device comprising the markers of FIGS. 36A and 36B coupled to an elongated tether. FIG. 43 is a cross-sectional view of the chest showing the delivery device delivering the marker of FIG. 42 and showing the method of introducing the delivery device into the chest to implant the marker in the vicinity of one or more lesions. FIG. 44 is a cross-sectional view of the chest showing the delivery device delivering the marker of FIG. 42 and showing a method for introducing the delivery device into the chest to implant the marker in the vicinity of one or more lesions. FIG. 45 is a cross-sectional view of the chest showing the delivery device delivering the marker of FIG. 42 and showing the method of introducing the delivery device into the chest to implant the marker in the vicinity of one or more lesions. FIG. 46 is a cross-sectional view of the chest showing the delivery device delivering the marker of FIG. 42 and showing the method of introducing the delivery device into the chest to implant the marker in the vicinity of one or more lesions. FIG. 47 is a cross-sectional view of the patient's body showing the markers being introduced into the patient's gastrointestinal system. FIG. 48 is a diagram showing details of markers that can be introduced into the patient's body shown in FIG. 47. FIG. 49 is a diagram illustrating details of the patient's body of FIG. 47, based on the location of a marker introduced at least partially into the patient's gastrointestinal system to perform a procedure. Indicates the installed equipment. FIG. 50A is a schematic diagram illustrating a signal from a probe that is incident on a marker and reflected from the marker, and FIG. 50B is a diagram illustrating a phase shift between the incident signal and the reflected signal.

  FIG. 1 illustrates one embodiment of a system 10 for locating a target tissue region within a patient's body, such as a tumor, lesion, or other tissue structure, in the chest or other location within the body. The system 10 generally includes a marker device or positioning wire 20 and a probe 30 that detects at least a portion of the positioning wire 20 using electromagnetic pulses, electromagnetic waves, or other signals such as radar. The positioning wire 20 includes an elongate member or shaft 22 that includes a proximal end 22a, a distal end 22b, and a target 26 on the distal end 22b. Optionally, system 10 may include one or more additional positioning wires and / or targets (not shown) in addition to positioning wire 20.

  The shaft 22 can be formed of a relatively hard material, such as a rigid rod or hollow cylindrical body, having sufficient column strength that allows the positioning wire 20 to be easily introduced percutaneously through tissue. The shaft 22 has a length sufficient to extend from a location outside the patient's body through the tissue to the target tissue region, for example about 0.5 to 10 cm. Optionally, the shaft 22 may be flexible or plastically deformable so that it can be bent if desired, or formed into a desired shape.

  Target 26 may include one or more features at the distal end 22b of shaft 22 that facilitate positioning of distal end 22b using probe 30. In the exemplary embodiment shown in the figures, the target 26 may be a spherical structure, for example, about 0.5 to 5 mm, for example, a sphere with a diameter larger than the distal end 22b of the shaft 22. Optionally, target 26 may include one or more features that enhance reception and reflection of electromagnetic signals. For example, the target 26 may be formed from one or more materials and / or may have a surface finish that enhances radar detection, for example, similar to the markers described herein. . In alternative embodiments, other shapes and / or geometries are provided, such as, for example, cubes, triangles, spirals, etc., which, like the other embodiments described herein, reflect radar reflections. And / or one or more corners and / or edges that can enhance detection.

  In addition, or alternatively, the target 26 may have a size and / or shape that is close to the size and / or shape of the lesion 42, for example, to facilitate positioning a desired margin around the lesion 42. You may have. For example, the size and / or shape of the lesion 42 can be measured in advance, and the target 26 can be selected from a target set of different size and shape and secured to the shaft 22 (or for each target). Each may be provided with a shaft). In addition, or alternatively, if multiple positioning wires and / or targets are provided, the shape and / or the shape of each target can be used to easily distinguish the targets from each other, for example, using the probe 30. Features may be different.

  In one embodiment, shaft 22 and target 26 can be integrally formed from the same material. Alternatively, the target 26 may be formed of a different material than the shaft 22, such as adhesive bonding, welding, soldering, interference fit, screws, or other cooperating connectors, etc. May be fixed to the distal end 22b. Thus, in this alternative, the target 26 can be formed of a material that enhances radar detection of the shaft 22.

  Optionally, when implanting multiple targets, surface, shape, and / or additional material features that allow each target to distinguish a particular target relative to one or more other targets You may have. For example, each target may be one that absorbs or reflects a specific electromagnetic signal specific to that target, and can be used to uniquely identify the target.

  In another option, the positioning wire 20 may include one or more anchor elements 24 on the distal end 22b, such as near the target 26, but the target 26 itself is such that the anchor element 24 is unnecessary. The positioning wire 20 can be sufficiently stabilized. As shown, the anchor element 24 comprises a plurality of barbs 24 (two shown) that extend in opposite directions, such as at an angle away from the shaft 22, eg, away from the target 26 proximally. Yes. Thus, the barbs 24 are configured to secure the positioning wire 20 in place after the positioning wire 20 is inserted into the tissue, for example, while the positioning wire 20 is advanced distally through the tissue, Subsequent pulling to the proximal side can be prevented. For example, the barbs 24 are sufficiently flexible so that the barbs 24 are compressed against or near the shaft 22 to facilitate advancement, for example, minimizing the profile of the positioning wire 20, and further shown in the figure. Thus, it can be elastically biased to return outward in the lateral direction.

  The probe 30 may be a portable device having electromagnetic signal transmission / reception capability such as a micro power impulse radar (MIR) probe. For example, as shown in FIG. 1, a probe 30 includes a first end 30a intended to be placed against or near a tissue, such as a patient's skin or subcutaneous tissue, and a second that a user can hold. The handheld device having the opposite end 30b may be used. Still referring to FIG. 10, the probe 30 generally comprises one or more antennas, such as a transmit antenna 32 and a receive antenna 34, one or more processors or controllers 36, and a display 38.

  Referring to FIG. 10, processor 36 is required to generate one or more controllers, circuits, signal generators, gates, generate signals to be transmitted by transmit antenna 32, and / or process signals received by receive antenna 34. Others (not shown) may be provided. The components of the processor 36 may comprise any desired discrete components, solid state elements, programmable devices, software components, etc. For example, as shown in the figure, the probe 30 includes an impulse generator 36b connected to the transmission antenna 32 to generate a transmission signal, such as a pulse generator and / or a pseudo noise generator (not shown), and a reception An impulse receiver 36c that receives a signal detected by the antenna 34 may be provided. The processor 36 alternately operates the microcontroller 36a, the impulse generator 36b, and the impulse receiver 36c to transmit electromagnetic pulses, electromagnetic waves, or other signals via the antenna 32, and is reflected via the antenna 34. A range gate control 36d for receiving an electromagnetic signal may be provided. Exemplary signals that can be used include microwaves, for example, radio waves such as micro impulse radar signals in the very low bandwidth region.

  In the exemplary embodiment, each antenna 32, 34 is a coplanar antenna, a single-ended elliptical antenna (such as a UWB antenna, a dipole and patch antenna, or a diamond dipole antenna with an angled physical profile). SEA), patch antennas, and others. Alternatively, instead of providing separate antennas 32, 34, processor 36 may alternately operate a single antenna as a transmit antenna and a receive antenna (not shown).

  For example, each antenna 32 and 34 is connected to Progress in Electromagnetics Research B, Vol. It may be a TEM horn antenna as disclosed in “TEM Horn Antenna for Ultra-Wide Band Microwave Breast Imaging” published in US Pat. No. 13,59-74 (2009). Alternatively, each antenna 32, 34 is disclosed in US Patent Publication No. 2008/0071169, published March 20, 2008, and Microwaves, Antennas, & Propagation, IET, Volume 1, Issue 1. 2 (April 2007), pp. It may be a patch antenna as described in Nilavalan et al., “Wideband Microstrip Patch Antenna Design for Breast Cancer Tumor Detection” published on 277-281. The patch antenna can be connected to an enclosure (not shown) filled with dielectric material to facilitate use with a micro impulse radar.

  In another alternative embodiment, each antenna may be a waveguide horn, for example as shown in FIG. 10B. As shown in the figure, the antenna 32 'includes a case 32A in which the first end 32B is closed, the second end 32C is open, and the waveguide 32D is mounted therein. . The wall of case 32A is, for example, Emerson & Cuming Microwave Products, N.E. V. It may be lined with an absorbent material 32E such as a broadband silicone absorbent material such as Ecosorb-FGM40 sold by the company. The volume of the case 32A may be filled with a dielectric 32F having a relative dielectric constant of 10, for example. In an exemplary embodiment, the antenna 32 'is, for example, about 3 to 10 GHz (3-10 Ghz), with a width of about 15x15 mm and a length of about 30 mm between the first and second ends 32B-32C. A square waveguide horn configured to operate in a wide frequency band (UWB) may be used. The open end 32B is directed outward from a probe with an antenna 32 'mounted therein, for example, the open end 32B transmits and / or receives signals as described herein for the antenna 32'. It may be in contact with or coupled to the tissue intended.

  The signal from the impulse receiver 36c may be filtered using the microcontroller 36a before being further processed, displayed, stored, communicated, etc., or may be filtered, for example, de-cluttered. ) And the forming circuit 36e. The circuit 36e may receive a signal from the antenna 34 such as, for example, return echo noise or reflected waves, simplify the signal using, for example, LPF, and / or digitally adapt as desired. It may include a filtering and / or pulse shaper. The microcontroller 36a then reads the received and / or processed signals to recognize the spatial relationship of the target 26, such as distance, angle, direction, etc., or other structure relative to the probe 30, as further described below. can do. Exemplary embodiments of the processor and / or other components included in the probe 30 are disclosed in US Pat. Nos. 5,573,012 and 5,766,208 to McEwan.

  In an alternative embodiment, the probe 30 can be configured to operate as a magnetic radar system as disclosed in US Pat. No. 6,914,552 to McEwan. For example, the probe 30 may comprise a magnetic field excitation source, such as an electromagnet (not shown), connected to a generator and / or a current coil driver (not shown). The generator and / or current coil driver can be provided inside or outside the probe 30. For example, the probe induces a magnetic field at a marker or other target, causing vibrations at specific frequencies that the radar unit can identify and / or recognize between the two poles to provide distance measurements or position coordinates. Such probes are used when the target is implanted in tissue, bone, or body fluid that has a relatively high impedance or dielectric constant that attenuates the radar pulse that reaches the target or the reflected signal that reaches the radar antenna. It is beneficial to.

  Referring to FIG. 10, a probe display 38 is connected to the microcontroller 36a to display to the user of the probe 30 information obtained via antennas 32, 34, such as space or image data. For example, as described further below, the display 38 simply provides distance, angle, direction, and / or other data based on predetermined criteria, such as, for example, the relative position of the target 26 relative to the probe 30. Reading may be performed. FIG. 10A is a diagram illustrating an exemplary embodiment of the output of display 38 that may be provided, which display may include an array of arrows or other displays 38a and a distance readout 38b. For example, the microcontroller 36a analyzes the received signal, determines in which direction the marker (not shown) is placed relative to the probe 30, activates the appropriate arrow 38a, and determines the distance to the marker (eg, , “3 cm” is displayed). In this way, the user can recognize in which direction the marker is located and how far away in that direction, thereby providing guidance to the target tissue region in which the marker and marker are implanted in the user. I will provide a.

  In addition or alternatively, the display 38 may be, for example, a real-time image of the area where the probe 30 is pointing, such as beyond the first end 30a of the probe 30, operating parameters, etc. Information can be provided. Optionally, the probe 30 may comprise one or more other output devices in addition to or alternatively to the display 38. For example, the probe 30 may include one or more speakers (not shown) such as one or more LEDs or other light sources that provide acoustic output, visual output, such as spatial information, operating parameters, Such information may be provided. For example, the speaker or LED may be activated when the probe 30 reaches a predetermined threshold distance from the marker, eg, a desired margin, or may be activated when the distance is closer. good.

  Optionally, the probe 30 may comprise other configurations or components such as one or more user interfaces, memories, transmitters, receivers, connectors, cables, power supplies, etc. (not shown). . For example, the probe 30 may comprise one or more batteries or other internal power sources that operate the components of the probe 30. Alternatively, the probe 30 may include a cable (not shown) that can be connected to an external power source, such as a standard AC power source, to operate the components of the probe 30.

  Referring to FIG. 10, the user control 37 may comprise one or more input devices such as a keypad, touch screen, individual buttons, etc. (not shown). The user control 37 allows the user to perform simple actions such as turning the probe 30 on and off, resetting the probe 30, etc., or more complex control of the probe 30 is possible. For example, user control 37 can adjust the sensitivity of probe 30 or other parameters, remotely capture, store, transmit data, and the like.

  Optionally, the probe 30 may include an internal memory 36f in which data acquired via the antennas 32, 34 and / or the microcontroller 36a can be recorded or stored. For example, the microcontroller 36a can automatically record data during operation or can be instructed to selectively save the data in the memory 36f. Additionally or alternatively, the microcontroller 36a can send data to one or more external devices, eg, for storage, display, etc. For example, the probe 30 may include one or more cables (not shown) to transmit these data and / or the probe 30 may be a transmitter and / or receiver (not shown). ), For example, wirelessly transmitting data and / or receiving commands via radio frequency, infrared, or other signals.

  As shown in FIGS. 1 and 10, all of the internal components of the probe 30 can be provided in a housing or case 39 to make the probe 30 self-contained. For example, the case 39 may be relatively small and portable so that the entire probe 30 can be held in the user's hand. Alternatively, as shown in FIG. 1, the first end 30 a of the case 39 can be formed of the same material as the other parts of the case 39 or a different material. For example, the first end 30a can be formed of a material that readily accommodates, for example, a path for electromagnetic signals from the transmit antenna 32 and / or to the receive antenna 34 without substantial interference. Optionally, the material can be selected to reduce interference, match impedance, or easily send and receive signals out of the patient's body via probe 30. In addition, or alternatively, if desired, the probe 30 may include a handle, finger grip, and / or other mechanism (not shown) that facilitates holding or manipulating the probe 30. May be.

  Alternatively, as shown in FIG. 11, a probe instrument 130 is provided that includes a separate controller 139 that includes one or more components in a case remote from the handheld probe 131. For example, the handheld probe 131 may include an elongated housing 131a having one or more antennas 132 at the tip 131b. The controller 139 may include one or more processors that control the antenna 132, display 138, etc., as in the embodiments described above. The handheld probe 131 can be connected to a processor in the controller 139 by one or more cables 133. For example, an impulse generator, impulse receiver, and / or gate control may be provided in the case of the controller 139 and optionally in the housing 131a if desired. In one embodiment, the cable 133 can be removably connected to a connector (not shown) of the controller 139 to electrically connect the antenna 132 of the handheld probe 131 to the electronics of the controller 139. Thus, although the handheld probe 131 may be a disposable, single use device, the controller 139 can be used in multiple procedures by connecting a new handheld probe 131 to the controller 139. This can also be applied outside the field of surgery, as further described below, and remains accessible and / or visible if desired.

  Referring to FIGS. 2A-5, the positioning system 10 of FIG. 1 can be used, for example, during a medical procedure such as a chest biopsy or tumor removal surgery to facilitate positioning of, for example, a lesion or other target tissue region 42. And / or facilitating excision and / or removal of the specimen from the chest 41 or other body structure. It should be noted that although the system 10 has been described as being particularly useful for positioning breast lesions, the system 10 can be used for positioning other objects in other areas of the body, such as those described herein. Can also be used.

  Prior to performing this procedure, target tissue regions such as tumors and other lesions can be identified using conventional methods. For example, as shown in FIG. 2A, a lesion 42 in the chest 41 is identified using mammography and / or other images, and a decision to remove the lesion 42 is made. A dashed line 44 surrounding the tumor 42 defines a “clear” margin and displays, for example, the size and shape of the desired tissue specimen 46 to be removed during the procedure. For example, margin 44 is selected to ensure that the remaining tissue after removal of specimen 46 is not substantially cancerous or other undesirable cells. In an exemplary embodiment, the distance between the outer boundary of the lesion 42 and the outer edge or margin 44 of the tissue specimen 46 is between about 1-10 mm, such as at least about 2 mm or at least about 1 cm.

  Referring to FIGS. 2A and 2B, the positioning wire 20 may be introduced percutaneously through the tissue 40, for example, from the patient's skin 48 through the intermediate tissue until the target 26 is located within the lesion 42. it can. In the exemplary embodiment, positioning wire 20 can be introduced through a delivery sheath (not shown). This sheath can also be pre-positioned using a needle and / or dilator (not shown), similar to the cannula 340 described herein with reference to FIGS. For example, a delivery sheath having a cannula or sharp tip can be introduced into the lesion 42 through the skin 48 and intermediate tissue 40 using, for example, ultrasound or x-ray imaging as guidance, and then the positioning wire 20 is cannulated. You can proceed through. Alternatively, a needle with a pointed tip can be advanced through the tissue, and then the delivery sheath can be advanced over the needle (not shown), for example with a dilator between the needle and the delivery sheath. Once the delivery sheath is positioned and extends from the skin 48 to the lesion 42, the needle and dilator are removed. The distal end 22b of the positioning wire 22 is then advanced through the delivery sheath until the target 26 is located within the lesion 42 and the delivery sheath is removed. Optionally, the positioning wire 22 comprises one or more markers (not shown) at or near the target 26 at the distal end, for example, a radiopaque marker or a marker that generates sound waves. The distal end 22b of the target 26 and / or the positioning wire 22 may be easily imaged. External imaging may be performed during and / or after introduction of the positioning wire 20 to ensure that the target 26 is correctly positioned within the lesion 42.

  If the positioning wire 20 comprises a fixation element, such as a barb 24, the barb 24 is compressed inward as the positioning wire 20 advances through the delivery sheath. When the target 26 is located within the lesion 42, the delivery sheath is withdrawn, and the barbs 24 elastically expand outward into the nearby tissue. In this manner, the barbs 24 on the distal end 22b of the shaft 22 fix the positioning wire 20 to the lesioned part 42, for example, so that the target 26 is substantially fixed at a fixed position in the lesioned part 42. Also good. In addition or alternatively, a bandage, tape, or the like (not shown) may be used to secure the proximal end 22a of the positioning wire 22 to the patient's skin 48, for example, You may make it prevent movement.

  After the positioning wire 20 is properly positioned and / or secured, the first end 30a of the probe 30 is, for example, near the patient's skin 48, typically above the lesion 42, as shown in FIG. Alternatively, it is placed in contact with it and / or is placed and actuated substantially towards the target 26. A transmitting antenna 32 (not shown, see FIG. 10) of the probe 30 emits an electromagnetic signal 31 that is reflected by the target 26 through the tissue 40. This signal 33 is reflected and returns to the receiving antenna 34 of the probe 30 (not shown, see FIG. 10). Probe 30 may be, for example, a distance 52 between target 26 and first end 30a of probe 30 (and patient skin 48 if first end 30a of probe 30 is in contact), etc. The spatial relationship between the target 26 and the first end 30a of the probe 30 is based on, for example, the distance traveled by the signal 31, the time passage between the transmission of the signal 31 and the reception of the reflected signal 33, etc. ,decide. Optionally, the probe 30 may determine the relative angle between the target 26 and the first end 30a to facilitate, for example, determining the correct direction for ablation.

  In one embodiment, the signal received by the microcontroller 36a of the probe 30 (not shown, see FIG. 10) is filtered or analyzed to determine, for example, the size, shape, or other of the target 26. Based on the feature recognition, the target 26 is positioned. In this way, the microcontroller 36a can automatically recognize the target 26 and distinguish it from other structures within the patient's body. Alternatively, the microcontroller 36a can simply position the object that reflects the signal back to the probe 30 that estimates and positions the target 26. For example, the microcontroller 36a calculates the distance 52 from the first end 30a of the probe 30 and / or the angle relative to an axis extending perpendicular to this end to display spatial information on the display 38. . This information facilitates the positioning of the target 26 and thus the lesion 42, for example, the tissue overlying the lesion 42 by providing the direction and depth of incision to access the target tissue region containing the lesion 42. Provide guidance to the surgeon to remove

  In addition, or alternatively, other information can be displayed on the display 38 if desired. For example, the display 38 provides a distance 54 between the target 26 and the outer margin 44 of the target tissue specimen 46 and can easily define the target size and shape of the tissue specimen 46 to be removed at this distance. In order to determine the distance 54, the probe 30 determines a predetermined distance between the desired margin 44 and the target 42, for example, based on preset parameters programmed in the processor 36 of the probe 30. Alternatively, it may be automatically subtracted based on the dimensions provided to the microcontroller 36a by the user via a user control 37 (not shown, see FIG. 10) immediately before the procedure, for example.

  With continued reference to FIG. 3, optionally, the probe 30 can be placed in or near the skin 48 and in the acquired spatial information if desired. Such information makes it easier for the surgeon to determine the path to take an optimal approach for resection, such as, for example, the shortest path to the lesion 42, or allows the surgeon to three-dimensionally with respect to the lesion 42. Assist with orientation. After determining the distance 52 between the patient's skin 48 and the target 26 from the desired location on the skin 48, the tissue 40 is excised to arrive at a predetermined outer edge 44 of the tissue specimen 46, as shown in FIG. . For example, the patient's skin 48 is incised at the location where the probe 30 is placed, and the intermediate tissue is excised using known methods until a depth corresponding to the margin 44 is reached. Optionally, anytime during the ablation, the probe 30 and the acquired spatio-temporal information are placed against or near the exposed tissue to verify this approach and / or the depth of the ablation. it can.

  Still referring to FIG. 4, if desired, if the surgeon believes that the desired margin 44 has been achieved, another length measurement is made by the probe 30 to determine that the desired distance 54 to the target 26 has been achieved. Check. For example, the first end 30a of the probe 30 is placed in contact with the bottom surface of the excised tissue region, the signal 31 is transmitted by the transmitting antenna 32, the signal 33 is received by the receiving antenna 34, and the probe 30 is excised. The distance between the bottom surface of the tissue region and the target 26 can be determined. After confirming that the desired margin 44 of the tissue specimen 46 has been reached, the tissue specimen 46 is removed or removed using conventional tumor excision techniques, leaving the target 26 in the removed specimen 46. Can do. If desired, for example, the distal end 22b of the shaft 22 is cut off, the connector (not shown) between the shaft 22 and the target 26 is removed, or otherwise, the target 26 is separated from the shaft 22 to Facilitate removal.

  Referring to FIG. 5, if desired, the probe 30 has been excised, for example, to confirm that the desired margin 44 has been achieved around the target 26 and consequently around the lesion 42. It may be used to analyze the specimen 46. As shown in the figure, a transmission signal 31 is transmitted by the probe 30, and a signal 33 is reflected by the target 26 and received by the probe 30. At this time, the probe 30 determines and displays the distance 54 and / or other spatial information. In this way, it can be confirmed that a predetermined organizational margin has been achieved.

  6-9, another exemplary embodiment of a system 110 for positioning a lesion or other tissue structure, such as a plurality of non-palpable lesions 142, is shown. The system includes a probe 30 and a plurality of implantable markers or targets 120. The probe 30 is a portable device and can transmit electromagnetic signals and receive reflected signals, similar to the embodiments described herein.

  The marker 120 comprises a plurality of implantable elements sized to be introduced through the tissue and into the area surrounding the lesion 142. For example, the marker 120 may be formed as a plurality of strips, cylinders, helices, spheres, etc., such as the target 26 described above in connection with FIG. 1 and / or, for example, FIGS. 23A-28C, 34A, 34B. , 41A and 41B, as well as the markers described herein, have a structure that enhances the reflection of electromagnetic signals transmitted by the probe 30.

  As shown in FIG. 6, the marker 120 has a rectangular or other shape, for example, having a length of about 0.5 to 4 mm, a width of about 0.5 to 2.0 mm, and a thickness of about 0.5 to 3.0 mm. It may be an elongated strip such as a marker. The marker 120 is made of metal or other material, for example, has a desired dielectric constant, and can enhance reflection by the probe 30. In addition, or alternatively, the marker 120 may be composed of a bioabsorbable material, for example, after the marker 120 is implanted into tissue and after several days, weeks, or months. And may be dissolved or absorbed in the tissue.

  Optionally, the marker 120 is formed of a radiopaque material, a radioactive material, and / or an echogenic material, eg, after introduction, during surgery, or the marker 120 remains in the patient's body after surgery. Then, after that, the imaging or monitoring of the marker 120 may be facilitated. In addition, if desired, each marker 120 has a surface, shape, and / or additional material configuration that can distinguish one or more of the markers from the others as described herein. You may have. For example, each marker 120 may modulate the incident signal from the probe 30 in a predetermined manner and / or absorb or reflect a special electromagnetic signal specific to the marker 120. Can be used to identify.

  In addition, as shown in FIG. 6, the system 110 also includes one or more delivery devices 160 that introduce markers 120 into the patient's body. For example, the delivery device 160 includes a proximal end 162a and a distal end 162b sized to be introduced through the tissue to a target tissue region (not shown) and carry one or more markers 120. A shaft 162 may be provided. The delivery device 160 includes a lumen 164 extending at least partially between the proximal and distal ends 162a, 162b of the shaft 162 and a continuous one or more markers 120 slidable within the shaft 162. Or a pusher member 166 that selectively delivers from the lumen 164 independently.

  As shown, the distal end 162b of the shaft 162 is beveled and / or pointed so that the shaft 162 can be introduced directly through the tissue. Alternatively, as described herein, delivery device 160 may be introduced through a cannula, sheath, or other tubular member (not shown) previously placed in the tissue. good. Optionally, distal end 162b may comprise a band or other structure formed, for example, of radiopaque, echogenic, or other material, such as fluoroscopy, ultrasound, electromagnetic Signals, etc. can be used to facilitate monitoring of the distal end 162b during introduction.

  As shown, the pusher 166 is connected to a piston or other element (not shown) disposed within the lumen 164 near the marker 120 and the piston that advances the piston to push the marker 120 out of the lumen 164. Or a plunger or other actuator 168. As shown, the plunger 168 can be manually advanced to deliver one or more markers 120 continuously from the lumen 164. Alternatively, a trigger device or other automatic actuator (not shown) may be provided at the proximal end 162b of the shaft 162 to fully advance the piston with each movement, eg, from the distal end 162b to the individual marker 120. May be delivered.

  With reference to FIGS. 6-9, an exemplary method of using a marker 120 and probe 30 to locate a lesion or other target tissue region 142 within the chest 41 or other tissue structure is shown. As shown in FIGS. 6 and 7, a marker 120 may be implanted into the tissue 40 to depict a desired margin or volume 144 of the tissue specimen 146 to be excised. For example, the shaft 162 of the delivery device 160 may be inserted percutaneously through the patient's skin 48, through the intermediate tissue 40, and using external imaging, etc. to guide the distal end 162b to the desired location. Thus, the distal end 162b can be disposed in or around the lesion 142. When in place, the plunger 168 can be advanced (or the shaft 162 retracted relative to the plunger 168) to deliver the marker 120 to the tissue. Delivery device 160 may be advanced to another location and / or completely removed from chest 41 and advanced through another location on skin 48 to the target tissue region to deliver, for example, one or more markers 120. You may make it do.

  Alternatively, delivery device 160 may carry a single marker 120 and multiple delivery devices (not shown) may be provided to deliver each marker 120. Additionally or alternatively, a stereotaxic device (not shown) is used to recognize the position of one or more delivery devices or lesions 142 in the form of a desired three-dimensional array within the patient's body, for example. Other configurations may be introduced. In a further alternative, the marker 120 can be replaced with a plurality of positioning wires similar to the wire 10, one or more catheters (not shown) that can be delivered sequentially or simultaneously, and the like. Optionally, the catheter, wire, or other device can be expanded, for example, in a distal region (not shown) to facilitate the expansion and / or positioning of the specimen volume or region.

  In the exemplary embodiment shown in FIGS. 6 and 7, for example, the marker 120 surrounds the lesion group 142 that cannot be palpated before or during the surgery to remove the sample volume around the lesion 142. Select the distance 156 between the outer edge 144 of the tissue specimen 146 and the lesion 142 so that the volume of the removed tissue is sufficient to ensure a clear margin, similar to the method described above. Can be selected to remove the volume of.

  As shown in FIG. 7, after implanting the marker 120, the probe 30 is placed against or near the patient's skin 48 (e.g., a signal is sent to or received from the tissue 40). The probe 30 need not be in contact with the patient's skin 48), and the probe 30 can be used to provide a distance 152 (and / or other spatial information) between the probe 30 and the marker 120, as in the above-described embodiment. ) Can be measured. In particular, the signal 31 emitted from the probe 30 is received by the marker 120, reflected and returned to the receiver in the probe 30 as a signal 33, and the probe 30 uses this signal between the patient's skin 48 and the marker 120. The distance 152 is measured.

  Next, the tissue 40 surrounding the lesioned part 142 is excised until it hits one of the markers 120 as shown in FIG. At this point, another measurement can be performed using the probe 30 to ensure the correct ablation depth. Next, the probe 30 is rearranged as shown by a dotted line in FIG. 8, and another marker 120 is arranged around the peripheral portion 144 of the tissue specimen 146. Using the result of the distance measurement, a desired margin volume for excision around the lesion 142 can be measured. This procedure can be repeated as desired to easily measure the desired margin based on the distance of the marker 120 while excising the tissue specimen 146 around the lesion 142. The tissue sample 146 includes the marker 120, and all the markers 120 may be removed together with the tissue sample 146. Alternatively, a desired margin may be defined in the marker 120 so that the marker 120 remains in the chest after the tissue specimen 146 is removed. In this alternative, the marker 120 may be bioabsorbable or inert and remain permanently on the patient's chest 41.

  Referring to FIGS. 11-15, another illustrative example of identifying one or more lesions 142 in the chest 41 and / or removing a tissue specimen 146 (shown in FIGS. 14A-15A) that includes the lesions 142. A system and method are shown. Similar to the embodiments described above, the system includes one or more markers 220 and probe device 130 to locate the lesion 142 and / or to reliably achieve the desired margin of the tissue specimen 146 removed from the chest 41. Making it easy. The probe instrument 130 includes a handheld probe 131 coupled to a processor 139 having one or more processors that control the operation of the probe 131 as described above. As also mentioned above, the handheld probe 131 has an elongate housing 131a with one or more antennas 132 on or in the tip 131b at one end of the probe 131, which is connected to the skin. 48 or other tissue and / or substantially in the direction of marker 220 and / or lesion 142.

  The processor 139 may comprise one or more processors that control the antenna 132, the display 138, etc., as in the embodiments described above. The handheld probe 131 is connected to the processor 139 by one or more cables 133. For example, an impulse generator, impulse receiver, and / or gate control can be provided in the processor 139, which are controlled to transmit and receive signals via the antenna 132.

  Optionally, as shown in FIGS. 14 and 14A, the handheld probe 131 includes, for example, an ablation structure 133 extending from the distal end 131b of the housing 131a. In one embodiment, the ablation structure 133 is, for example, a relatively flat, pointed ablation device that is about 10-50 mm long and / or about 1-10 mm wide and secured to the tip 131b of the probe 131. May be. Alternatively, the ablation structure 133 can be retracted, for example, if the ablation structure 133 is initially housed in the housing 131a, but is selected if a layer of tissue is to be removed to access tissue near the marker 220. You may make it expand. In a further alternative, the ablation structure 133 includes a pointed blade or edge so that the patient's skin 48 and / or the underlying tissue layer 40 can be easily dissected.

  First, as shown in FIG. 11, in use, one or more markers 220 are implanted into a target tissue region using, for example, the markers and / or methods described herein. For example, the probe 131 is connected to the processor 139 by the cable 133, and the tip 131 b of the probe is arranged with respect to the skin 48. By operating the probe 131, for example, the initial distance from the tip 131 b of the probe 131 to the marker 220 is measured using the antenna 132, thereby providing an approximate distance to the lesion 142. This distance measurement is displayed on the display 138 of the processor 139 and / or provided to the user, for example as shown in FIG. In addition or alternatively, as described above, the speaker may measure distance, such as using synthetic speech, one or more tones that identify the corresponding distance, etc. to identify the distance. Also good. For example, the processor 139 can analyze the received signal to measure the actual distance from the tip 131b of the probe 131 to the marker 220, and can provide the actual distance via a speaker. Alternatively, the speaker provides a tone corresponding to a predetermined threshold, for example, a first tone for a first threshold, a second tone or a plurality of tones for a second closer distance, It can be displayed that these are closer to the marker 220.

  As shown in FIG. 11, using the probe 131 on the first side of the chest 41, the measurement value L1 is obtained, while using the probe 131 ′ arranged on the second side opposite to the chest 41. Thus, a measured value L2 larger than L1 is obtained. Using this information, the surgeon decides to initiate a first side resection. This information is to provide a shorter path that requires less tissue excision than the path initiated from the second side, as shown in FIG.

  Referring to FIG. 13, a desired margin L <b> 3 can be specified around the marker 220 and subsequently around the lesioned part 142 using the probe 131. For example, if a desired margin L3 of 1 cm is desired, the probe 131 displays or provides the actual distance L1 from the probe 131 to the marker as shown on the display 138, thereby allowing the outside of the margin L3. Display that the probe 131 remains. Alternatively, when the processor 139 recognizes the desired margin L3, the display 138 provides the difference between the actual distance L1 and the desired margin L3 (ie, L1-L3), thereby allowing the surgeon to Notify the resection depth necessary to obtain the margin.

  Optionally, as shown in FIGS. 14 and 14A, when the probe 131 includes a rounded resection tool 144, the resection tool 144 is deployed from the tip 131b of the probe 131 (if not permanently deployed). Advance through the tissue 40 toward the marker 220, for example, until a desired margin L3 is obtained. The probe 131 then uses the rounded resection tool 144 and / or the tissue around the marker 220 using one or more additional resection tools, scalpels, or other tools (not shown). Is operated to excise.

  As shown in FIGS. 15 and 15A, the tissue sample 146 including the marker 220 and the lesion 142 was removed from the chest 41. Optionally, the probe 131 is used to confirm that the desired margin L3 is achieved around the marker 220, thereby removing sufficient tissue from the chest 41, similar to the previous embodiment. Make sure.

  With reference to FIGS. 16A and 16B, a probe 231 comprising one or more markers 220, a finger sack 231 a carrying one or more antennas 232, and a processor 239 connected to the antenna 232 by a cable 233, for example. Yet another embodiment of a system comprising: The finger sack 231a is a flexible sleeve, which has, for example, an open end 231b for inserting the finger 90 and a closed end 231c, and has a sufficient length to be surely received beyond the finger 90. For example, the finger sack 231a, like a surgical or examination glove, expands to receive and house the finger 90 while the finger sack 231a compresses inward so that the finger 90 does not slip during use. It can be formed of an elastic material such as a relatively thin latex layer, natural or synthetic rubber having sufficient flexibility.

  As shown in the figure, an antenna 232 can be provided in the vicinity of the closed end 231c. For example, the antenna 232 may include a transmission antenna and a reception antenna (not shown) in the case as in the above-described embodiment. This case can be attached to the finger sack 231a, for example, near the closed end 231c, for example, by gluing with an adhesive, melting, one or more bands (not shown), and the like.

  The processor 239 operates one or more of the antennas 232 and / or processes signals received from the antennas 232, for example, connected to the antenna 232 with a cable 233 and comprising a display 238, similar to the above-described embodiments. It has the following components. In the illustrated embodiment, the processor 239 may include one or more clips 239a, straps, belts, clamps, or the like that removably secures the processor 239 to the user's arm inserting a finger into the finger sack 231a. (Not shown). For example, the clip 239a may be bent to extend partially around the user's forearm, and the clip 239a is flexible enough to open the clip and receive the arm therein It may be elastically closed to at least partially engage around. Alternatively, the processor 239 can be located in a case (not shown) located away from the patient and / or user, similar to the processor 139 described above.

  With further reference to FIGS. 17 and 18, in use, a surgeon or other user can place a finger 90, such as, for example, an index finger or thumb into the finger sack 231a and activate the processor 239 to Similarly, signals are transmitted and received via the antenna 232.

  As shown in FIG. 17, the finger 90 placed in the finger sack 231 a can be placed on the skin 48 of the patient, and a distance measurement can be obtained to identify the distance to the marker 220. When the tissue above the marker 220 is excised, the user places the finger 90 in the path created there as shown in FIG. 18 and directly feeds back the position of the marker 220 to the user, and then with respect to the finger 90 The position of the lesion 142 is fed back. Thus, this embodiment provides tactile feedback along with distance measurements to the probe 231 to facilitate excision and / or removal of the tissue specimen 146 including the marker 220 and the lesion 142. For example, as shown in FIG. 17, the first measurement distance L1 is obtained, and the necessary excision depth is notified to the user, while the measurement distance L2 is obtained as shown in FIG. 18 (corresponding to a desired margin). This notifies the user that sufficient excision has been performed and that the tissue specimen 146 can be separated and removed, as in the above-described embodiment.

  With reference to FIGS. 19-22, yet another system for locating and / or accessing a target tissue region including, for example, one or more lesions 142 is shown. In general, the system includes a probe instrument 330 that includes a handheld probe 331 connected to a processor 339, similar to the embodiments described above. For example, the probe 331 includes one or more antennas 332 and the processor 238 includes a display 338.

  In addition, the system includes a cannula or other tubular member 340 that includes a proximal end 342, a distal end 344, and a lumen 346 extending therebetween. Cannula 340 is a substantially rigid cylindrical body sized to receive probe 331 within lumen 346 as shown in FIG. As shown, the distal end 344 can be beveled, pointed, and / or configured to facilitate direct advancement through tissue. Alternatively, the distal end 344 may be tapered and / or rounded (not shown) and, for example, a needle may be introduced into the tissue 40, similar to the previous embodiment. Before or after, the cannula 340 may be advanced over the needle (not shown).

  Referring to FIG. 19, prior to use, the probe 330 is inserted into the lumen 346 of the cannula 340 and, for example, the antenna 332 is positioned proximate the distal end 344 of the cannula 340. Optionally, cannula 340 and / or probe 331 may include one or more connectors (not shown) that releasably secure probe 331 to cannula 340, for example, maintaining antenna 332 near distal end 344. On the other hand, if necessary, the probe 331 may be removed. Additionally or alternatively, cannula 340 may include one or more seals (not shown), such as within proximal end 342 and / or distal end 344, to place probe 331 within lumen 346 and / or. Alternatively, a substantially liquid tight seal may be provided when the probe 331 is removed. For example, a hemostatic seal (not shown) may be provided at the proximal end 342 to provide a seal that prevents fluid flow through the lumen 346 and to receive and house a probe 331 or other device (not shown) through the lumen. To do.

  Referring to FIG. 20, in use, the distal end 344 of the cannula 340 can be inserted through the patient's skin 48 and tissue 40 into the marker 220 using a probe 331 operating within the cannula 340. . As shown, the probe 331 transmits a signal 31 and the display 338 of the processor 339 displays a distance measurement L1 or other indication of the relative position of the marker 220 relative to the antenna 332 based on the reflected signal received by the antenna 332, Subsequently, the position of the marker relative to the distal end 344 of the cannula 340 can be provided. In this manner, the penetration depth and / or direction of travel of cannula 340 can be adjusted based on information provided by probe 331 and processor 339. For example, as shown in FIG. 21, the cannula 340 is advanced until the desired distance L2 is achieved, thereby causing the distal end 344 to move to the marker 220, eg, in the target tissue region near the lesion 142. Place it at a desired distance from

  Referring to FIG. 22, with the distal end 344 of the cannula 340 positioned at the desired location relative to the lesion 142, the probe 331 is removed and the cannula 340 is put in place as shown. The cannula 340 thereby provides a path to access the target tissue region, for example, to perform one or more diagnostic and / or treatment processes. For example, a needle or other tool (not shown) is advanced through the lumen 346 of the cannula to perform a biopsy and / or deliver fluid or other diagnostic or therapeutic material to the target tissue region. Additionally or alternatively, one or more devices (not shown) are introduced through cannula 340, for example, to remove tissue specimens, including lesion 142, to deliver radiation therapy and / or other processes. When access is no longer needed, the cannula 340 is simply removed. Alternatively, if the cannula 340 needs to be repositioned during the process, the probe 331 is re-introduced into the lumen 346 and the cannula 340 is re-introduced into the tissue using the probe 331 providing further guidance. Deploy.

  FIGS. 11 to 22 show a marker 220 that can be implanted in the tissue 40 or placed in the tissue 40 using the same method as described above, for example, in or near the lesion 142. As shown, the marker 220 generally comprises a generally elongated body having a relatively narrow central stem portion between the spherical ends. The marker 220 may be formed of a desired material and / or may have surface features similar to other markers in the material. This feature facilitates positioning of the markers 220 and / or distinguishing the markers 220 from each other.

  Referring to FIGS. 23A-28C, further examples of markers are shown and these examples can be used with any of the systems and methods described herein. For example, referring to FIGS. 23A-23C, a first exemplary marker 320 is shown, which includes a core wire 322 carrying a plurality of beads or segments 324. The core wire 322 is, for example, an elongated member having a solid or hollow structure with a diameter or other maximum cross section of about 0.5 to 2 mm and a length of about 1.0 to 10 mm. The core wire 322 is formed of an elastic or superelastic material and / or a shape memory material such as, for example, stainless steel, nitinol, and the core wire 322 is biased and deployed in the tissue as further described below. When it does, it becomes a predetermined shape. Alternatively, the core wire 322 may be substantially rigid and the marker 320 may maintain a fixed shape, such as a straight or curved shape, as further described below.

  As best seen in FIGS. 24A-24C, the bead 324 may comprise, for example, a plurality of individual annular bodies, each defining a generally cylindrical or spherical portion. The beads 324 can be formed of a desired material such as a metal such as stainless steel, nitinol, titanium, etc., a plastic material, or a synthetic material, as in the above-described embodiment. The beads 324 can be formed by performing injection molding, casting, machining, cutting, polishing, and the like. Further, the desired finish may be applied to the beads 324 by, for example, sandblasting, etching, chemical vapor deposition, or the like.

  As best seen in FIG. 24B, each bead 324 includes a path 326 that receives a core wire 322 (not shown, see, eg, FIGS. 23A-23C) therein. The beads 324 may be nested and at least partially nested adjacent to each other when secured on the core wire 322, and may further change shape and / or surface of the marker 320 such that the core wire 322 changes shape, for example. It has a structure. Further, the bead 324 includes a surface geometry that enhances the reflection of electromagnetic waves, such as radar, for example, with one or more grooves around the periphery of the bead. The groove comprises a plurality of faces with adjacent faces defining a steep angle, such as about 45 ° to 135 °, or about 90 °. For example, as best seen in FIG. 24C, each bead 324 comprises a first convex or spherical end 324a and a second concave end 324b having a flat surface 324d. As shown in FIG. 25B, the adjacent bead 324 ′ is between the flat surface 324d ′ of the concave end 324b ′ of the first bead 324 and the surface 324e ′ of the spherical end 324a ′ of the adjacent bead 324 ′. Groove 324c '. Surfaces 324d 'and 324c' define steep corners between them, which define, for example, an angle of about 90 ° to enhance radar detection. .

  Optionally, as shown in FIGS. 25A and 25B, the bead 324 ′ has a desired surface finish 324f ′ adapted to customize the reflected signal generated when the electromagnetic signal hits the surface of the bead 324 ′. May be. For example, the surface finish 324f 'may be formed in the bead 324' and include a plurality of holes or indentations having a desired diameter and / or depth. As described above, the probes and processors described herein analyze such reflected signals and, for example, when multiple markers are implanted or placed within a patient's body. In addition, specific markers can be uniquely identified.

  Referring to FIGS. 23A-23C, during assembly, a plurality of beads 324 can be placed over and secured to the core wire 322 to provide the final marker 320. For example, the core wire 322 is continuously inserted into the path 326 of the bead 324 until the bead 324 extends substantially between the ends of the core wire 322. The beads 324 may be bonded to the core wire 322 with, for example, an individual bead 324 crimped to the core wire 322, an end of the core wire 322 crimped or expanded, or slid over the full bead 324. It can be fixed to the core wire 322 by melting or the like. In this way, the beads 324 are attached almost permanently to the core wire 322 to prevent the beads 324 from moving, or to allow the beads 324 to float freely over the core wire 322. As a result, the marker 320 may be easily bent or shaped.

  Alternatively, the marker 320 may be formed of a single piece of material to form, for example, a workpiece with a shape and surface defined by the beads 324 shown in FIG. 23A. In this alternative, the core wire 322 may be eliminated, or a path for receiving the core wire 322 may be formed in the workpiece.

  In one example, the marker 320 can define a substantially fixed shape, such as a linear shape as shown in FIGS. 23A and 23B, or a curved shape as shown in FIGS. 23D and 26A-26C. For example, the core wire 322 of the marker 320 is sufficiently flexible that the marker 320 can be straightened to facilitate, for example, loading of the marker 320 into the delivery device and / or delivery of the marker 320, and 320 may be biased to have a curved shape or other linear shape.

  As shown in FIG. 23D, the marker 320 may be biased to have a waveform such as, for example, in-plane meandering or other curved shapes. For example, the core wire 322 may be made of an elastic or superelastic material having a shape set so as to have a waveform by applying a bias to the core wire 322, and may be elastically stretched to have a linear shape. The beads 324 may be spaced apart or nested such that the beads 324 do not substantially interfere with the deformation of the core wire 322 between the linear shape and corrugation, eg, loading the marker 320 into a delivery device. , And / or the introduction of the marker 320 into the body can be facilitated.

  Alternatively, as shown in FIGS. 34A and 34B, for example, a bias may be applied to form a tapered spiral shape including a relatively wide intermediate region 320a ′ ″ between the tapered end regions 320b ′ ″. A marker 320 ′ ″ may be provided. Another alternative embodiment of the marker 320 "" is shown in Figs. 41A and 41B, which is biased to have a generally uniform helical shape in diameter. One advantage of the markers 320 ′ ″ and 320 ″ ″ is that they relate to the reflection angle and / or position of the markers 320 ″ ′ and 320 ″ ″ with respect to the probe antenna (not shown). Rather, providing a relatively constant and / or consistent radar cross section (RCS). For example, even if the markers 320 ′ ″ and 320 ″ ″ are visible along the helical axis as shown in FIGS. 34B and 41B, for example, the markers 320 ′ ″ and 320 ″ ″ As shown in 34A and 41A, it provides an RCS that is almost the same as when viewed horizontally with respect to the helical axis.

  Optionally, any of the markers described herein can be provided as a passive marker, an active marker, an active reflector, or an active transponder. For example, referring to FIGS. 23A-23D, the marker 320 is a simple “passive reflector”. That is, the marker 320 simply reflects the incident wave or signal that hits the marker 320. The incident signal is reflected at various surfaces and / or ends of the marker 320, for example, thereby providing a reflected wave or signal that is detected by the probe as described further herein. One drawback of passive markers is that the radar cross section (RCS) changes based on the probe antenna and the aspect angle of the marker 320, which changes the intensity of the signal reflected back from the marker 320.

  Alternatively, the marker 320 may comprise one or more structures that provide an “active reflector”. That is, the marker 320 comprises one or more electronic circuits that modulate the signal that strikes the marker 320 in a predetermined manner without applying external energy or power to the reflected signal. Such markers can be active with modulation dipoles or other types of active reflective antennas, including one or more very low power diodes and / or FET transistors, for example, that operate with very little current. A reflective wireless element may be provided. The active reflector provides substantially unique radar signal characteristics within the implanted tissue environment that can be detected and identified with the probe. In addition, the active reflector provides a relatively large signal back to the probe, for example, thereby allowing the target RCS to be maintained regardless of the shape of the antenna.

  For example, the marker 320 may comprise one or more circuits or other elements (not shown) connected to or embedded in the marker 320 that bias the incident wave or signal from the probe. In the exemplary embodiment, a nanoscale semiconductor chip is carried on the marker 320, which has its own energy source and thus processes the signal as it is received or reflected at the marker 320. It only modulates. An exemplary embodiment of an active reflector that can be provided on the marker is disclosed in US Pat. No. 6,492,933.

  50A and 50B show an example of modulation of the reflected signal B relative to the incident signal A that can be achieved using an active reflector. Incident signal A represents a wave or signal transmitted by a probe (not shown), such as any of the probes described herein. As shown in FIG. 50A, incident signal A hits a surface such as any of the markers described herein and is reflected back to reflected signal B. In a passive reflector, the surface of the marker simply reflects the incident signal A, and thus the reflected signal B has the same characteristics as the incident signal A, eg, band, phase, and other characteristics.

  Conversely, in an active reflector, a marker modulates the incident signal A in a predetermined manner, for example, changing the frequency and / or phase of the reflected signal B. For example, as shown in FIG. 50B, the circuit on the marker changes the ultra-wideband radar incident signal A into a reflected signal B having a relatively narrow band, such as about 1 to 10 gigahertz. This again includes a predetermined phase shift. The relatively narrow band reflected signal B enhances the RCS of the marker, thereby enhancing probe detection.

  Further, as shown in FIG. 50B, the phase of the reflected signal B is 90 ° modulated with respect to the incident signal A. If the marker is the only one in this phase shift, individual phase shifts make it easy for the probe to identify and distinguish the marker from other structures, such as other markers that differ in phase shift, tissue structure, etc. become. For example, when multiple markers are implanted in a patient's body, each marker circuit has a different phase shift (eg, + 90 °, + 180 °, −90 °, etc.) and / or bandwidth in the reflected signal. Configure. In this way, the probe can easily identify and distinguish markers from each other and / or other structures of the patient's body.

  One advantage of the active reflector is that the circuit itself does not require a power source. Thus, the size of the circuit is substantially reduced and, if desired, the marker can be implanted into the patient's body for extended periods or even permanently, and the marker can be removed from the probe. In response to the signal, marker positioning and / or identification can be facilitated.

  In a further alternative, an “active marker” having one or more features that generate a detectable energy in response to an excitation energy criterion may be provided. An example of such an active marker is disclosed in US Pat. No. 6,363,940.

  In a further alternative, an active transponder is provided. This resends or “responds”, for example, the MIR probe energy that provides the uniqueness of the radar signal characteristics within the embedded tissue environment. The active transponder comprises one or more electronic circuits embedded in or carried by the marker and has an internal energy source such as one or more batteries, capacitors, etc. In one exemplary embodiment, the active transponder comprises a microwave receiver and / or transmitter, a data processing and storage element, and a return signal modulation system. The active transponder generates microwave energy in response to the excitation microwave energy emanating from the probe and returns a larger signal to the probe that was possible only with, for example, a passive marker. For example, the marker generates RF energy containing data formatted according to its own radar signature and / or frequency from the probe. In the exemplary embodiment, the active transponder is quadrature modulated and outputs a single sideband (SSB) signal to either the upper sideband (USB) or the lower sideband (LSB) of the MIR radar. Such a transponder offers the possibility of multi-channel operation over the RF spectrum.

  Referring to FIGS. 29A and 29B, a delivery device 260 is provided, which is sized to take tissue for introduction into, for example, a target tissue region within the chest 41, and may include a marker 320 (or optionally a plurality of markers, And a shaft 262 having a proximal end 262a and a distal end 262b. The delivery device 260 includes a lumen 264 that extends between the proximal and distal ends 262a, 262b of the shaft 262, and is slidable within the shaft 262 from the lumen 264 to the markers described in FIGS. 23A-23D. A pusher member 266 for delivering 320; As shown, the distal end 262b of the shaft 262 is beveled and / or pointed so that the shaft 262 can be introduced directly through the tissue. Alternatively, delivery device 260 may be introduced through a cannula, sheath, or other tubular member (not shown) that is placed through tissue, such as described herein. May be. Optionally, the distal end 262b may comprise a band or other structure made of, for example, radiopaque, sound-generating material, or other material, which is described herein. As described, the distal end 262b can be easily monitored during introduction.

  As shown in FIG. 29A, pusher member 266 includes a distal end 267 disposed within lumen 264 near marker 320 and a plunger or other actuator 268 that advances distal end 267 to push marker 320 out of lumen 264. With As shown in FIG. 29B, when the distal end 264 of the delivery device 260 is advanced to a desired position within the tissue 40, the shaft 262 is retracted relative to the plunger 268 to sequentially push the marker 320 out of the lumen 264. Alternatively, a trigger device or other automatic actuator (not shown) may be provided at the proximal end 262a of the shaft 262 to deliver the marker 320 from the distal end 262b.

  Referring to FIGS. 26A-26C, an alternative embodiment of a marker 320 '' is shown, which is substantially the same as the marker 320 shown in FIGS. 23A-23D, for example carrying a plurality of beads 324 ''. Core wire 322 '' to be included. However, unlike the marker 320, the core wire 322 "is biased to have a helical shape, for example, the marker 320" is biased to a helical structure as shown in the figure. Thus, the marker 320 '' can be straightened to facilitate loading into a delivery device, such as, for example, the delivery device 260 shown in FIGS. 29A and 29B, and to return elastically to the helical structure. Can be biased.

  In an alternative embodiment, any of the markers 320, 320 ′, or 320 ″ can be at least partially formed of a shape memory material, for example, when the marker is biased when warmed to a target temperature, the desired shape You may make it take. For example, referring to the marker 320 of FIG. 24, the core wire 322 is formed of a shape memory material, such as Nitinol, and the core wire 322 is at an ambient temperature, such as 20 ° C. or lower, or at a lower temperature. The martensite state is reached, for example, the austenite state at a body temperature such as 37 ° C. or higher. In the martensitic state, the core wire 322 is relatively soft and malleable, for example, the marker 320 may be straightened and loaded into the delivery device 260 of FIGS. 29A and 29B. The shape memory of the core wire 322 is such that the material is temperature set or programmed so that when the core wire 322 is warmed to a target temperature, the core wire 322 is biased into a waveform, spiral, or other non-linear shape. Thus, even if the marker 320 is bent, linear, or deformed from a desired deployed shape while in the martensitic state, the marker 320 is once introduced into the patient's body. Or, when warmed to the target temperature, it is automatically biased to assume a deployed structure.

  Referring to FIGS. 27A-27C, another exemplary embodiment of marker 420 is shown. Similar to marker 320, marker 420 includes a core wire 422 that carries a plurality of beads or segments 424. Each bead 424 includes a plurality of grooves 424c that enhance the reflection of signals from a probe (not shown), for example, as described herein. The core wire 422 and the bead 424 can be manufactured and assembled in the same manner as in the above-described embodiment. For example, the bead 424 is freely rotated or fixed to the core wire 422. The groove 424c may be formed entirely on each bead 424, or may be defined by a cooperating surface of an adjacent bead (not shown), as in the above embodiment. The groove 424c may define a substantially flat surface or a curved surface, and these surfaces are coincident with steep edges that define corners that enhance radar detection.

  Optionally, as shown in FIGS. 28A-28C, alternative embodiments of spherical markers 520, 520 ′, 520 ″ are shown, which include grooves 524c, 524c ′ having different shapes and / or structures. 524c ''. Grooves 524c, 524c ', 524c "generate substantially different reflected signals, for example, as described above, allowing the probe processor to distinguish different markers based on the various reflected signals. In the embodiment shown in FIGS. 28A-28C, the markers 520, 520 ', 520' 'are made of a single piece material and do not comprise a core wire and multiple beads. Obviously, if desired, the markers 520, 520 ′, 520 ″ may be provided with a core wire and multiple beads, and / or the markers 420 of FIGS. 27A-27C may be formed of a single piece material if desired. It is.

  Referring to FIGS. 30A-31B, another embodiment of a delivery device 360 is shown, which is used to deliver a marker 320, such as the marker 320 shown in FIGS. 23A-23D, but is alternatively described herein. Any marker described in the book may be used. In general, the delivery device 360 includes a needle sized to be introduced through tissue into a target tissue region, such as within the chest 41, or other regular shaft 362 having a proximal end 362a and a distal end 362b; A lumen 364 extending between the proximal and distal ends 362a, 362b. The delivery device 360 also includes a pusher member 366 that is slidable within the shaft 362 and that delivers the marker 320 from the lumen 364. As shown, the distal end 362b of the shaft 362 is beveled and / or pointed so that the shaft 362 can be introduced directly through the tissue. Alternatively, delivery device 360 may be introduced through a cannula, sheath, or other tubular member (not shown) that is placed through tissue, such as described herein. May be. Optionally, the distal end 362b may comprise a band or other structure made of, for example, radiopaque, sound generating material, or other material, which is described herein. As described, distal tip 362b can be easily monitored during introduction, for example, using x-ray or ultrasound imaging, also as described herein.

  As shown in FIGS. 30B and 31B, the pusher member 366 includes a distal end 367 that is initially positioned proximate the marker 320 within the lumen 364, for example, as shown in FIG. 30B. Push member 366 is generally fixed relative to handle 370 of delivery device 360, while shaft 362 can be retracted, for example, to expose marker 320, as further described below. For example, as shown in FIG. 30B, the proximal end 366a of the pusher member 366 can be secured to a push holder 372 that is loaded into the handle 370.

  The shaft 362 is connected to a shaft holder 374, which can slide within the handle 370. For example, the shaft holder 374 is slidable axially from a first or distal position shown in FIG. 30B to a second or proximal position shown in FIG. 31B. Thus, with the shaft holder 374 in the first position, the distal end 367 of the pusher member 366 is displaced proximally from the distal end 362b of the shaft 362, thereby causing the shaft lumen 364, as shown in FIG. 30B. Provides sufficient space to receive the marker 320 therein. When the shaft holder 374 is oriented in the second position, the shaft 362 is retracted until the distal end 362b of the shaft 362 is positioned near the distal end 367 of the pusher member 366, as shown in FIG. 31B. The distal end 367 of the pusher member 366 prevents the marker 320 from moving proximally during the retraction of the shaft 362 so that the marker 320 is continuous from the lumen 364 of the shaft 362 as shown in FIGS. 33 and 33A. To expand to.

  Shaft holder 372 and shaft 362 are biased to a second position, but are selectively left in the first position to load and deliver marker 320 therewith, for example, using delivery device 360. Anyway. For example, as shown in FIGS. 30B and 31B, the handle 370 may include a spring or other mechanism received in a groove 378 in the housing and adjacent to the shaft holder 374. In the first position, the spring 376 is compressed as shown in FIG. 30B, and in the second position, the spring 376 is relaxed as shown in FIG. 31B or the potential energy is low. is there.

  The handle 370 includes an actuator that selectively holds and releases the shaft holder 374 and shaft 362 in the first position. For example, as shown in FIG. 30B, the shaft holder 374 in the first position until the proximal end 374a of the shaft holder 374 is adjacent to or engages the distal end 372a of the push holder 372. Holder 374 rotates within handle 370. Alternatively, the handle 370 may include one or more other structures (not shown) that selectively engage the shaft holder 374 in a first position. As shown in FIG. 31B, when the shaft holder 374 rotates within the handle 370 and the proximal end 374a is disengaged from the distal end 372a of the push holder 372, the proximal end 372a moves within the handle 370. It can move freely to the proximal side. Thus, as the shaft holder 374 rotates, the spring 376 automatically points the shaft holder 374 proximally, thereby deploying the marker 320. Other actuators, such as a detent or lock that can be opened, such as a releasable detent or lock that automatically retracts the shaft 362 in the advanced position and automatically retracts the shaft 362 when the actuator is actuated. It is obvious that it is provided in 374.

  Referring to FIGS. 32 and 33, similar to the embodiments described above, the delivery device 360 may be used to enter, for example, the chest 40 or other tissue structure within a target tissue region that includes one or more lesions 142. Marker 320 can be delivered. Once the marker 320 is delivered, the target tissue region can be positioned using the marker 320, for example, in any of the systems and methods described herein.

  With reference to FIG. 35, yet another embodiment of a marker device 610 is shown, which includes a marker 620 coupled to a tether or other elongated element 630. The tether 630 may be, for example, a suture formed of a bioabsorbable material or a non-bioabsorbable material, such as a flexible material, a hard material, a wire formed of a malleable material, or the like. When introduced into the target tissue region, it has a length sufficient to stretch the patient's body. The marker 620 is similar to the marker 320 ′ ″ shown in FIGS. 34A and 34B or other embodiments described herein, such as the distance of the tether 630, similar to the positioning wire described herein. The retraction end 634 can be releasably or substantially permanently attached. An elongated tether 630 extending from the marker 620 provides an additional reference for the location of the marker 620 when implanted in tissue. For example, the tether 630 guides the surgeon to the correct location of the marker 620 and / or analyzes the presence of the marker 620 within the removed tumor volume during a tumor removal surgery. The tether 630 can also be used to place a tag that helps identify the orientation of the marker 620 within the target tissue, and may be left in place or removed if desired.

  36-41, a delivery device 660 and method for implanting a marker device 610 within a target tissue region, such as, for example, implanting a marker 620 within a non-palpable lesion 142 in the chest 41, is shown. Has been. Similar to the embodiments described above, the delivery device 660 has a proximal end 262a and a distal end 262b sized for introduction through tissue into a target tissue region, such as the chest 41, and a shaft carrying the marker device 610. 262. Delivery device 660 is slidable to deliver a marker 620 from lumen 664 within shaft 662 and lumen 664 extending at least partially between proximal end 662a and distal end 662b of shaft 662. A push member 666 is provided. As shown, the distal end 662b of the shaft 662 is beveled and / or pointed so that the shaft 662 is introduced directly through the tissue. Alternatively, delivery device 660 may be introduced through a cannula, sheath, or other tubular member (not shown) that is disposed through tissue, such as described herein. May be. Optionally, distal end 662b may comprise a band or other structure made of, for example, radiopaque, sound-generating material, or other material, so that during introduction, As also described herein, distal end 662b can be easily monitored.

  As shown in FIG. 36, the pusher member 666 includes a lumen 667 through which the tether 630 is slidably received. Thus, during manufacture or prior to use, marker device 610 is loaded into delivery device 660 such that marker 620 is positioned within lumen 664 near distal end 662b and tether 630 passes through lumen 667 of pusher member 666. Extending out of the plunger 668 connected to the pusher member 666. If the marker 620 is biased in a spiral or other shape, the marker 620 can be straightened when loaded onto the shaft 662 as shown in FIG. The marker device 610 can be implanted to replace the wire positioning procedure prior to tumor removal surgery or when performing a biopsy. Alternatively, the marker device 610 can be delivered via a core needle biopsy instrument or a vacuum core needle system (not shown).

  For example, as shown in FIG. 36, during surgery, the distal end 662b can be inserted through the tissue into a target tissue region, such as the lesion 142, for example. As the distal end 662b of the delivery device 660 is advanced to the desired location within the tissue, the shaft 662 retracts from the lumen 664 relative to the plunger 668 coupled to the pusher member 666, as shown in FIG. A marker 620 is delivered. As shown, the marker 620 automatically and / or elastically changes shape when deployed and returns to the tapered helical shape shown in FIG. Referring to FIG. 38, the delivery device 660 is removed from the patient's body, leaving the marker 620 in the target tissue region, such as the lesion 142, for example. The tether 630 simply slides through the pusher member 666 until the end is exposed from the chest 41, for example, as shown in FIG.

  Optionally, as shown in FIG. 40, the tether 630 can be disconnected from the marker 620 and the marker 620 can be placed in place within the lesion 142. For example, the tether 630 may have a weak area (not shown) that is destroyed immediately upon application of a predetermined tension, immediately next to the marker 620. Alternatively, the tether 630 includes a threaded distal end 634 or other connector that can be disconnected from the marker 620, for example, rotating the tether 630 to loosen the screw on the distal end 634 to cause the marker 620. Can be removed. Alternatively, the tether 630 may remain attached to the marker 620 during the next tumor surgery or other procedure.

  Referring to FIG. 42, another exemplary embodiment of a marker device 610 'is shown, which is generally the same as the marker device 610. That is, it includes a tether 630 and a marker 620 '. However, the marker 620 'may be the same as the marker 320 "" "shown in FIGS. 41A and 41B. 43-46 illustrate an exemplary embodiment of a method for implanting a delivery device 620 'and a marker device 610', which are generally the same as described in FIGS. 36-40.

  While the systems and methods described herein relate to breast lesions, such as the probe 30 described above, implant or introduce one or more markers or targets into other areas of the patient's body. Subsequent positioning can be performed using the probe. For example, one or more targets can be placed in or near the bile duct, femoral artery or vein, fallopian tube, or other body lumen for subsequent positioning. This target is carried by the catheter, wire, or other delivery device from the access site into the lumen of the body lumen, for example, by anchoring the catheter or wire, or anchoring the marker into the wall or body lumen of the body lumen. It can be fixed there by stopping at.

  For example, FIG. 47 shows the gastrointestinal tract 3 of a patient performing one or more diagnoses and / or treatments. As shown, the catheter 1 carrying the marker 2 can be introduced into the patient's GI tract 3 via, for example, the mouth or rectum. As seen in FIG. 48, the catheter 1 includes a marker 2, similar to other markers described herein, for example. For example, the marker 2 is shown in FIGS. 23A-23C and has a structure similar to the one or more beads 320 described above. The catheter 1 and marker 2 can be advanced to a desired position within the GI tract 3 using, for example, fluoroscopy, ultrasound, or other external imaging.

  The marker 2 is then positioned using a probe, such as the probe described herein, thereby determining the position within the GI tract 3. It is self-evident that other body lumens can be similarly positioned to facilitate access to the body lumen, for example, from the outside of the patient's body with minimally invasive techniques. For example, as shown in FIG. 49, the marker 2 is used to locate a specific position within the GI tract 3, facilitate the puncture of the wall of the body lumen, place the body lumen therein, and clip the body lumen Doing, cutting, ligating, closing, etc. FIG. 49 is a cross-sectional view showing the abdominal part 4 inhaled by, for example, conventional laparoscopic surgery. A probe 5 similar to the probe described herein can be inserted into the access cannula 6 to scan and / or detect the position of the marker 2 on the catheter 1. Next, the position of the probe 5 with respect to the marker 2 is visualized using the laparoscope 7. Once the marker 2 is positioned, the access sheath 8 is used to advance access to the GI tract 3 at the desired location, for example to perform one or more diagnostic and / or treatment procedures. As desired, the marker 2 and catheter 1 are removed when access is complete or after this procedure is complete.

  In an exemplary embodiment, a catheter is used to introduce a marker into the fallopian tube, then a needle or other device is introduced in a minimally invasive manner, for example, through the patient's skin and tissue over the marker, Accessing the fallopian tube, for example, ligating, cauterizing, or cutting or closing the fallopian tube. Alternatively, once the marker is placed in the bile duct, the bile duct is accessed using endoscopic access with guidance of the probe 30 to perform, for example, surgery in the patient's intestine. In a further alternative, a marker is placed on a branch that communicates with the length of the femoral artery or other vein that is to be removed, and the probe 30 is used to identify each branch outside the vessel. For example, each branch can be cut, ligated, cauterized, and / or separated, and a blood vessel of this length can be separated and extracted from an adjacent blood vessel.

  In a further alternative, one or more markers can be implanted in the target tissue structure to position the treatment using the system described herein. For example, the marker may carry one or more drugs, radioactive materials, or other therapeutic substances that are released over an extended period of time in or around the target tissue region being implanted. After a sufficient amount of time has elapsed, for example, when the therapeutic substance is almost completely gone or has been sufficiently delivered, the probe 30 is used to position the marker and, for example, easily regenerate the marker using minimally invasive techniques To do and / or to remove.

While the invention is susceptible to various modifications and alternatives, specific details are shown by way of example in the drawings. However, it should be understood that the invention is not limited to the specific forms or methods disclosed individually, but on the contrary covers all modifications, equivalents, and alternatives falling within the scope of the claims. It should be.

Claims (22)

In a positioning system for a target tissue region within a patient's body,
A marker having an elongated core member, wherein the core member is biased in a non-linear shape, but is resilient so that the core member is straightened to facilitate introduction of the marker into the delivery device A marker that is flexible and automatically returns to the non-linear shape when the core member is deployed in tissue;
After one or more antennas transmitting micro impulse radar signals into the patient's body and receiving reflected signals from the patient's body, the reflected signals are analyzed and implanted into the patient's body A probe for identifying the marker,
The marker is the so reflected signal to enhance the identification of the marker, see contains electronic circuitry that is configured to modulate the micro impulse radar signal corresponding to the marker,
A system wherein the electronic circuit is configured to phase shift the reflected signal and the probe identifies the phase shift to distinguish the marker from other objects in the patient's body. . In a system for locating a target tissue region within a patient's body,
One or more antennas for transmitting a micro impulse radar signal to the patient's body and receiving a reflected signal from the patient's body, and analyzing the reflected signal for one or more in the patient's body A probe for identifying an object;
With a marker of the size to be implanted in the patient's body,
The marker has an elongated core member that is biased in a non-linear shape but is elastic so that the core member is straightened to facilitate introduction of the marker into the delivery device. to a flexible, automatically returns to the non-linear shape when the core member is deployed in the tissue,
The marker further comprises an electronic circuit configured to modulate a micro impulse radar signal that hits the marker such that the reflected signal enhances identification of the marker;
A system wherein the electronic circuit is configured to phase shift the reflected signal and the probe identifies the phase shift to distinguish the marker from other objects in the patient's body. . In a system for locating a target tissue region within a patient's body,
A delivery device comprising a shaft including a proximal end and a distal end sized for introduction into a target tissue region through tissue within a patient's body, carrying an implantable marker in or around the target tissue region However, the marker has an elongated core member, and the core member is biased in a non-linear shape, but the core member is straightened to facilitate introduction of the marker into the delivery device. A delivery device that is elastically flexible and automatically returns to the non-linear shape when the core member is deployed in tissue;
A probe comprising one or more antennas for transmitting a micro impulse radar signal into a patient's body and receiving a reflected signal from the patient's body, the probe being disposed in the vicinity of the target tissue region Occasionally, immediately give a probe for detecting the target tissue region, or implanted markers around,
The marker further comprises an electronic circuit configured to modulate a micro impulse radar signal that hits the marker such that the reflected signal enhances identification of the marker;
A system wherein the electronic circuit is configured to phase shift the reflected signal and the probe identifies the phase shift to distinguish the marker from other objects in the patient's body. . The system of claim 3, wherein
The system wherein the delivery device is configured to sequentially deliver a plurality of markers within or around the target tissue region. The system according to any one of claims 1 to 3 ,
The system, wherein the electronic circuit is carried on the core member. The system according to any one of claims 1 to 5 ,
A plurality of beads coupled to the core member, the beads further comprising a plurality of flat surfaces and a sharp corner to enhance the reflection of the micro impulse radar signal and facilitate the identification of the marker. System. The system according to any one of claims 1 to 6 ,
The electronic circuit comprises one or more diodes and an FET transistor, and the electronic circuit is an active reflector that modulates a micro impulse radar signal that hits the marker such that the reflected signal enhances the identification of the marker A system configured to provide an antenna. The system according to any one of claims 1 to 7 ,
The system wherein the core member has a length of 10 millimeters (10.0 mm) or less. The system according to any one of claims 1 to 8 ,
The system wherein the core member is biased in a spiral shape. The system of claim 9 , wherein
The system wherein the core member is biased in a tapered helical shape. The system according to any one of claims 1 to 10,
The system further comprising an elongated tether extending from one of the core member or a bead coupled thereto. The system according to any one of claims 1 to 8 ,
A system wherein the marker is configured to implant independently of other devices or tethers. The system of claim 6 , wherein
A system wherein one or more of the beads has a predetermined surface finish and modulates the signal reflected from the one or more beads to enhance the identification of the marker. The system according to any one of claims 1 to 13 ,
A system wherein the probe transmits a micro impulse radar signal in the ultra wide band (UWB) of about 3 to 10 gigahertz (3-10 GHz). 15. The system according to any one of claims 1 to 14 ,
The system wherein the probe comprises a substantially flat patient contact surface for placement on a patient's skin adjacent to the target tissue region. The system according to claim 1 or 2,
A system further comprising a delivery device for introducing the marker into a patient's body. The system of claim 16 , wherein
The system wherein the delivery device comprises one of a needle and a cannula. The system according to any one of claims 1 to 17 ,
The system comprising: an output device that provides spatial information based on a spatial relationship of the marker to the probe. The system of claim 18 , wherein
The system wherein the output device comprises a display. The system of claim 18 , wherein
The system, wherein the spatial information includes a distance from an end of the probe that is positioned relative to tissue and that faces the target tissue region to the marker. 21. The system according to any one of claims 1 to 20 ,
The probe includes a processor that automatically identifies the marker from data acquired using the one or more antennas and determines spatial information based on a spatial relationship of the marker to the probe. A system that is configured to: The system according to any one of claims 1 to 21 ,
A portable device having a first end configured to be positioned with respect to tissue of a patient's body, whereby the one or more antennas are connected to tissue within the patient's body. A system characterized by directing.

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